FDA recognition of ISO 11986 Second edition 2010-11-01 [Rec# 10-67] will be superseded by recognition of ISO 11986 Third edition 2017-11 [Rec# 10-112]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 10-67] until September 28, 2019. After this transition period, declarations of conformity to [Rec# 10-67] will not be accepted.